Vascular disorder treatment device

Abstract

Apparatus and methods for treating the vasculature of a patient are described. Embodiments may include a permeable implant made from a plurality of elongated filaments woven together. The implant may have a first unconstrained preset configuration consisting of a dome portion and a collar portion with a distal end having an outer surface with a convex shape. The implant may have a second deployed configuration in which the first unconstrained configuration is inverted. The second deployed configuration has an open distal end and an inner surface with a concave shape.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 63 / 276,537, filed November 5, 2021, which is expressly incorporated by reference herein in its entirety for all purposes.

[0002] (Technical field) Embodiments of the devices and methods herein relate to blocking the flow of fluid to an intracavity or vascular defect in a mammalian body. More particularly, embodiments herein relate to devices and methods for the treatment of a vascular defect in a patient, including some embodiments specifically relating to the treatment of a cerebral aneurysm in a patient. [Background technology]

[0003] The mammalian circulatory system consists of the heart, which acts as a pump, and the vascular system, which transports blood to various locations in the body. Due to the forces exerted on the blood vessels by the flowing blood, the blood vessels can undergo various vascular disorders. One common vascular disorder, known as an aneurysm, results from the abnormal widening of the blood vessels. Aneurysms usually form as a result of the weakening of the blood vessel wall, followed by the swelling and dilation of the blood vessel wall. For example, if an aneurysm is present in an artery of the brain, and this aneurysm ruptures, causing intracranial hemorrhage, which can be fatal.

[0004] Surgical techniques for the treatment of cerebral aneurysms generally involve a craniotomy, which requires the creation of an opening in the patient's skull through which instruments can be inserted, allowing the surgeon to operate directly on the patient's brain. Some surgical approaches require the retraction of the brain to expose the parent vessel from which the aneurysm originates. Once access to the aneurysm is gained, the surgeon clamps the neck of the aneurysm with a clip, preventing the inflow of arterial blood into the aneurysm. If the clip is placed correctly, the aneurysm is removed within minutes. Surgical techniques are an effective treatment for many aneurysms. Unfortunately, surgical techniques for treating such conditions involve extensive invasive surgery, often requiring lengthy procedures under anesthesia, which poses high risks for the patient. Thus, such procedures generally require the patient to be in good physical condition in order to be a good candidate for surgery.

[0005] A variety of alternative, less invasive procedures have been used to treat cerebral aneurysms without resorting to major surgery. One approach to treat aneurysms without the need for invasive surgery involves the placement of a sleeve or stent within the vessel and across the site of the aneurysm. These flow diverter devices maintain blood flow within the vessel while lowering the pressure inside the aneurysm. Some stents are expanded to the appropriate size by inflating a balloon catheter, called balloon-expandable stents, while others are self-expanding and elastically expandable. Some stents are commonly covered with a sleeve of polymeric material, called a graft, to form a stent-graft. Stents and stent-grafts are commonly delivered through a delivery catheter to a preselected location adjacent to the vascular defect. In the treatment of cerebral aneurysms, the use of covered stents and stent-grafts is very limited because they may inadvertently occlude small perforating vessels near the vascular defect being treated.

[0006] Furthermore, current uncovered stents are generally inadequate for treatment alone. To allow the stent to pass through the microcatheters used in the small cerebral vessels, the density of the stent is usually reduced so that upon expansion there is little stent structure bridging the neck of the aneurysm. That is, the stent does not block a significant amount of flow and allows blood in the aneurysm to clot. Thus, the stent is generally used in combination with a vascular occlusion device, such as the coils mentioned above, to achieve occlusion of the aneurysm.

[0007] Some procedures involve the injection of embolic or filling materials into the aneurysm. The delivery of such vaso-occlusion devices or materials can be used to promote hemostasis or to completely fill the aneurysmal cavity. Vaso-occlusion devices can be placed in the vascular system of the human body, typically via a catheter, to block the flow of blood through the blood vessel in which the aneurysm resides by forming an embolus, or to form such an embolus within an aneurysm arising from the blood vessel. A variety of implantable coil-type vaso-occlusion devices are known. The coils of such devices may be formed into a secondary coil shape by themselves, or may be formed into any of a variety of more complex secondary shapes. Vaso-occlusion coils are commonly used to treat cerebral aneurysms, but suffer from several limitations, including low packing density, compression due to the hydrodynamic pressure of blood flow, poor stability in wide-necked aneurysms, and complex and difficult deployment, as most aneurysm treatments by this approach require the deployment of multiple coils. Wound coils are less effective in treating certain physiological conditions, such as wide-necked cavities (e.g., wide-necked aneurysms), due to a high risk of migration from the treatment site.

[0008] Many aneurysm neck bridging devices with defect spanning portions or regions have been attempted, but none of these devices have met with significant clinical success or use. The main limitation in the adoption and clinical utility of these devices is the inability to position the defect spanning portion to ensure coverage of the neck. Existing stent delivery systems that are neurovascularly compatible (i.e., deliverable through microcatheters and highly flexible) do not have the required rotational positioning capabilities. Another limitation of many aneurysm bridging devices described in the prior art is their poor flexibility. Cerebral vasculature is tortuous, and high flexibility is required to effectively deliver to most aneurysm locations in the brain.

[0009] There remains a need for devices and methods for delivery and use in small, tortuous vessels that can substantially block blood flow to aneurysms, such as cerebral aneurysms, while reducing the risk of inadvertent aneurysm rupture or vessel wall damage. Additionally, there remains a need for methods and devices suitable for blocking blood flow in cerebral aneurysms for extended periods of time without significant risk of deformation, compression, or dislocation.

[0010] Intrasaccular occlusion devices are part of a new type of occlusion device used to treat various intravascular diseases, including aneurysms. They are often effective in treating such wide-necked diseases, i.e., large treatment areas. Intrasaccular occlusion devices have a structure that fits within the aneurysm and provides an occlusion effect on the aneurysm neck, helping to restrict blood flow into the aneurysm. The remainder of the device has a relatively conformable structure that fits within the aneurysm to help occlude all or part of the aneurysm. Intrasaccular devices usually conform to the shape of the treatment site. These devices also occlude a cross-section of the treatment site / aneurysm neck, thereby promoting clotting and causing thrombosis and occlusion of the aneurysm over time. In larger aneurysms, there is a risk of compaction, where the intrasaccular device migrates into the aneurysm and disengages from the neck area.

[0011] For any size aneurysm, there are many different sizes of occlusion devices from which the physician treating the aneurysm can choose, and these devices may vary in height and diameter. Implants may also have different expanded shapes, e.g., barrel or sphere. Thus, many different sizes and models of implants may have approximately the same volume as the aneurysm being treated, thus providing an acceptable "volume match" for the aneurysm.

[0012] Alternatively, the implant may be smaller than the full height of the aneurysm. Some devices are designed to fill only about half of the aneurysm. Such implants do not need to be volume matched and can be used for aneurysms of different sizes. However, these implants may not optimally cover the neck of a wide aneurysm. For example, a device with a tapered proximal end may not adequately cover the neck of a wide-necked aneurysm. Additionally, a poorly fitting device may migrate distal to the aneurysm and not be secured to the neck.

[0013] There is a need for an occlusion device that has a suitable size to treat aneurysms of different sizes having different neck sizes.

[0014] The following embodiments address this problem by utilizing a device with a pre-set expanded shape that can conform to and treat multiple sizes of aneurysms, including wide-neck aneurysms. Summary of the Invention [Means for solving the problem]

[0015] Occlusion devices are described that are used to treat a variety of conditions, including aneurysms and neurovascular aneurysms. In some embodiments, the occlusion device is configured as an intracapsular device. [Brief description of the drawings]

[0016] The above and other aspects, features, and advantages enabled by embodiments of the present invention will become apparent and clear from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings.

[0017] Various figures included show a closure device according to one or more embodiments.

[0018] [Figure 1] 1 shows a device for treating an aneurysm. [Figure 2A] 1 shows a schematic diagram of an exemplary device and an exemplary device for treatment of an aneurysm having an unconstrained configuration having an inverted shape with a closed distal end and an open proximal end. [Figure 2B] 1 shows a schematic diagram of an exemplary device and an exemplary device for treatment of an aneurysm having an unconstrained configuration having an inverted shape with a closed distal end and an open proximal end. [Diagram 3] 1 illustrates an exemplary device within a delivery catheter. [Figure 4A] 2A and 2B are schematic diagrams of an exemplary instrument, showing an exemplary instrument having an open distal end and a closed proximal end. [Figure 4B] 2A and 2B are schematic diagrams of an exemplary instrument, showing an exemplary instrument having an open distal end and a closed proximal end. [Figure 5A] An exemplary device is depicted as deployed within an aneurysm. [Figure 5B] An exemplary device is depicted as deployed within an aneurysm. [Figure 5C] An exemplary device is depicted as deployed within an aneurysm. [Figure 5D] An exemplary device is depicted as deployed within an aneurysm. [Figure 5E] An exemplary device is depicted as deployed within an aneurysm. [Figure 6] A tubular mesh is depicted having openings defined by loops of filaments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The embodiments presented generally relate to occlusion devices that can be used to treat aneurysms of different sizes.

[0020] One way to select a device for placement within a particular aneurysm is to match the volume of the device 110 to the volume of the aneurysm. For a device 110 having a permeable shell 140 with an approximately barrel-shaped or spherical shape, as seen in FIG. 1, a physician can select an implant according to a "+1 / -1" strategy. For example, the permeable shell 140 of the selected device 110 can have a diameter approximately 1 mm larger than the average diameter of the aneurysm and a height approximately 1 mm smaller than the minimum height of the aneurysm. By making the permeable shell 140 approximately 1 mm larger relative to the diameter of the aneurysm, a slight compressive force can be ensured on the implant after it is deployed within the aneurysm. This compressive force can help the permeable shell 140 maintain a stable position after implantation as blood flows into and out of the aneurysm. When the permeable shell 140 compresses its diameter by approximately 1 mm to fit within the aneurysm, it expands its height by approximately 1 mm, thereby allowing it to almost completely occupy the aneurysm's volume. That is, the selected permeable shell 140 is approximately volumetrically equal to the aneurysm, but initially has a larger diameter. This larger diameter provides friction against the aneurysm wall after deployment, and the "volume match" allows the permeable shell 140 to completely fill the aneurysm, thereby maintaining a stable position even as the implant is compressed over time by hemodynamic forces (represented by arrow 161) and thrombus contractile forces (represented by arrow 161).

[0021] For example, when treating an aneurysm having an average diameter of about 5 mm, a physician may choose to either have an instrument 110 having a diameter×height of 6×3, 6×4, or 6×5 (e.g., barrel shaped), or a spherical instrument having a diameter of about 6 mm. Similarly, an aneurysm having an average diameter of about 6 mm may be treated with an instrument 110 having a diameter×height of 7×3, 7×4, or 7×5 (e.g., barrel shaped), or a spherical instrument having a diameter of about 7 mm.

[0022] In alternative embodiments, the device can have an unrestrained, expanded, preset, heat-set, "free air" or unconstrained shape and have a different expanded or deployed shape when deployed within the aneurysm, where the device is constrained by the aneurysm wall. The expanded preset shape can be transformed into a different expanded shape by the compressive forces of the aneurysm wall. As seen in FIG. 2, the permeable shell 240 can have an unrestrained, expanded, preset, or heat-set configuration 244 as it exists in "free air", i.e., an umbrella or hat shape. In some embodiments, the expanded preset shape may be heat-set into an umbrella or hat shape and may have a recess near the marker band 70. As seen in FIGS. 4A-4B, when deployed, the recess may result in a flat bottom or proximal surface that better matches the wide neck shape. The shape of the recess may be optimized to achieve optimal deployment and sharpening performance characteristics. In the deployed configuration, the permeable shell may no longer have a recess at the proximal end such that the marker band is not recessed relative to a plane defined by the proximal-most point of the permeable shell. In other embodiments, the expanded preset shape may be heat set into an umbrella or hat shape and may not have a recess adjacent to the marker band 70.

[0023] As seen in FIGS. 2A-2B, the implant in the expanded, pre-set, heat-set, or unconstrained configuration may resemble an umbrella or hat in "free air". Each of the plurality of filaments forming the device may have a first end and a second end. In some embodiments, both the first end and the second end of each of the plurality of filaments may be gathered into a single hub or marker band 70. In other embodiments, only the first end of each of the plurality of filaments may be gathered into the hub or marker band 70. The plurality of filaments may be braided or looped to form a basket or cage. In some embodiments, an intermediate portion of each of the plurality of filaments may form a loop at the proximal end 218 of the unconstrained configuration 244.

[0024] The deployed preset configuration 244 may include a dome-shaped portion 212 that connects to a brim portion 214 in “free air”. The brim portion 214 may have a downwardly curved or slightly convex or angled shape. In some embodiments, the brim portion 214 may not be substantially flat, straight, or horizontal. The brim portion 214 may also optionally have a lip portion 215 that slopes downwardly from the brim at an angle different than the downward curve of the brim portion 214. The lip portion 215 may have a greater slope than the brim portion 214. The expanded preset unconstrained configuration 244 may be an inverted configuration having an outer surface and an inner surface. The hub or marker band 70 may be disposed within an interior cavity formed by the inner surface of the dome-shaped portion 212 such that the distal end 216 of the unconstrained, expanded, heat-set, or preset configuration 244 is inverted.

[0025] 3, the permeable shell 240 of the device 210 may have an elongated configuration that is radially constrained for delivery within a microcatheter. The hub or marker band 70 may be removably coupled to the pusher 170. In the elongated configuration, the permeable shell may extend distally from the hub or marker band 70.

[0026] As seen in FIGS. 4A-4B and 5A-5E, the permeable shell 240 may assume a different expanded shape 246 (other than a hat- or umbrella-shaped unconstrained preset "free air" configuration) when deployed within the aneurysm 160. The permeable shell 240 may be in an inverted configuration within the microcatheter 172, as seen in FIG. 3, where the permeable shell 240 extends distally from the hub or marker band 70 and the permeable shell has an open distal end 222. The permeable shell 240 may substantially conform to the shape of the aneurysm. The diameter of the distal end of the permeable shell may be larger (e.g., about 1 mm larger or at least about 1 mm larger) than the maximum diameter of the aneurysm, so that the sides of the permeable shell 240 may be compressed and the permeable shell may lengthen to a height greater than the height of the unconstrained expanded preset configuration 244. The lip 215 of the permeable shell 240 may extend outward at an angle similar to a tulip, bowl, cup, or teacup shape to increase friction and help maintain the permeable shell 240 positioned within the interior cavity of the aneurysm 160. The substantially flat portion 220 may occupy the opening of the aneurysm 160 at the neck. The substantially flat portion 220 in the deployed configuration may correspond to the sides and top of the dome portion 212 seen in FIG. 2A. The proximal portion of the permeable shell in the deployed configuration may have an inverted frusto-conical shape.

[0027] In one embodiment, the microcatheter 172 can be directed adjacent the neck of the aneurysm 160 to deploy the implant. As seen in FIGS. 5A-5E , the pusher 170 can advance the permeable shell 240 out of the microcatheter 172 and into the interior cavity of the aneurysm 160, the permeable shell 240 having an open distal end 222 with a lip 215. Because the permeable shell 240 is biased to its preset, heat-set, “free-air” configuration, the open distal end 222 continues to expand as the permeable shell advances further out of the distal opening of the microcatheter 172. As the permeable shell advances further out of the distal opening of the microcatheter 172, at least a portion of the sidewall of the permeable shell 240 can contact the wall of the interior cavity of the aneurysm 160, which can prevent the permeable shell 240 from assuming the preset, heat-set, “free-air” configuration. Instead, the permeable shell 240 conforms to the walls of the aneurysm 160 and assumes an expanded, deployed state resembling a bowl or tulip shape with an open distal end 222. The dome portion 212 in the heat-set configuration can be a substantially flat portion disposed over the neck of the aneurysm 160. As the permeable shell 240 is biased to its preset heat-set configuration, the side walls of the permeable shell (formerly the collar portion 212 and lip portion 215) can exert pressure against the aneurysm walls, thereby helping to keep the permeable shell 240 properly positioned within the aneurysm 160.

[0028] In another embodiment, the microcatheter 172 may be directed adjacent the neck of the aneurysm 160 to deploy the implant. The pusher 170 advances the permeable shell 210 out of the microcatheter 172 and into the interior cavity of the aneurysm 160, where the permeable shell 240 may be in a partially everted configuration with an open proximal end, the hub 70 located in the interior cavity of the domed portion 212, and the collar 214 restrained by the aneurysm wall. When the pusher 170 is withdrawn from the interior cavity, the permeable shell may evert such that the hub 70 no longer fits within the interior cavity of the domed portion 210. When the pusher 170 attached to the hub 70 is withdrawn proximally, the dome-shaped portion 212 may invert to assume the substantially flat portion 220 seen in FIGS. 4A-4B, while the flange-shaped portion 214 has an open distal end 222 in an expanded deployed state and can conform to the wall of the aneurysm to resemble a bowl or tulip shape.

[0029] The deployed shape of the implant may be an inversion of the unconstrained "free air" shape of the implant. As seen in FIGS. 4A-4B, after deployment within the aneurysm 160, the device 244 may have a bowl or tulip shape with a substantially flat portion 220 at the proximal end 224 and an open distal end 222. In a constrained expanded state within a vascular defect (e.g., an aneurysm), the proximal end 214 (see, e.g., FIG. 2B) of the unconstrained device may become the distal end of a constrained, expanded configuration 246 in the device deployed within the aneurysm. In the constrained or deployed configuration 246, in some embodiments, a loop made from an intermediate portion of each of the multiple filaments may form the edge of the open distal end 222.

[0030] 2A and 4A, the domed portion 212 may form a substantially flat portion 220 and the brim portion 214 may form an expanded device side 245. The length of the domed portion 212 and / or the substantially flat portion may be between about 2.5 inches (about 63.5 mm) and about 4.5 inches (about 114.3 mm), alternatively between about 2.8 inches (about 71.1 mm) and about 4.2 inches (about 106.7 mm), alternatively between about 3.0 inches (about 76.2 mm) and about 4.0 inches (about 101.6 mm), alternatively between about 3.2 inches (about 81.3 mm) and about 3.8 inches (about 96.5 mm).

[0031] The length of the collar 214 and / or the collar 214 plus lip 215 may be equal to or substantially equal to the height of the constrained expanded configuration 246. The length of the collar 214 and / or the collar 214 plus lip 215 in the preset "free air" configuration may correspond to the height of the expanded configuration, and may be between about 1.0 to about 3.0 inches (about 25.4 to about 76.2 mm), about 1.5 to about 3.0 inches (about 38.1 to about 76.2 mm), alternatively about 1.5 to about 2.5 inches (about 38.1 to about 63.5 mm), alternatively about 1.5 to about 2.25 inches (about 38.1 to about 57.2 mm), about 1.0 to about 2.0 inches (about 25.4 to about 50.8 mm). The length of the collar 214 and / or the collar and lip 215 in the preset "free air" configuration, which may correspond to the height of the expanded configuration, may be about 20% greater than the length of the substantially flat portion, alternatively about 30% greater, alternatively about 40% greater, alternatively about 50% greater. The length of the collar 214 and / or the collar and lip 215 in the preset "free air" configuration, which may correspond to the height of the expanded configuration, may be between about 20% and about 90%, alternatively about 30% and about 90%, alternatively about 40% and about 90%, alternatively about 50% and about 90% of the length of the substantially flat portion. In some embodiments, the length of the side adjacent the aneurysmal side wall may not change because it is defined by (1) the end of the flange (or the end of the lip, if a lip is present) and (2) the inflection point between the dome and flange.

[0032] Because the permeable shell 240 is heat set into a different, inverted shape relative to its expanded, deployed shape within the aneurysm, the permeable shell 240 may exert pressure against the walls of the aneurysm as it biases to assume its preset, inverted (or "free air") configuration. This pressure helps to maintain the permeable shell 240 in the proper position within the aneurysm 160. One advantage of the bowl-shaped device 210 is that a physician has fewer models to consider when determining the appropriate size for the aneurysm.

[0033] The permeable shell 240 of the device 210 may have a radially constrained elongated configuration for delivery within a microcatheter. The permeable shell 240 may have a hat-shaped expanded preset configuration 244 or an unconstrained configuration, which has a longitudinally shortened configuration relative to the radially constrained state. However, once deployed within the aneurysm 160, the permeable shell may assume a different expanded shape 246 (other than the hat-shaped preset configuration) in response to proximal withdrawal of the pusher and compressive forces from the aneurysm wall, as seen in FIGS. 4A-4B. The permeable shell 240 may substantially conform to the shape of the aneurysm. The diameter of the distal end of the permeable shell may be larger (e.g., about 1 mm larger or at least about 1 mm larger) than the maximum diameter of the aneurysm, so that the sides of the permeable shell 240 may be compressed.

[0034] In the deployed configuration, in some embodiments, the hub may not be recessed relative to the mesh at the proximal end of the permeable shell, hi some embodiments, the expanded deployed configuration may not have a recess at the proximal end formed by the outer surface of the permeable shell.

[0035] The implant's permeable shell 240 may be made from a braided tubular mesh. Mechanisms and methods for forming tubular braided meshes are described in further detail in U.S. Pat. No. 8,261,648, U.S. Pat. No. 8,826,791, and U.S. Patent Publication No. 2021 / 0275184, which are expressly incorporated by reference in their entirety for all purposes. The mesh or braided portion may be made from a plurality of filaments in a woven structure. The plurality of filaments that make up the mesh or braided portion may be made from Nitinol, stainless steel, expanded filled tubes (e.g., platinum or tantalum core with a Nitinol jacket), platinum, platinum alloys such as platinum / tungsten, superelastic metals such as NiTiNibY, high strength metals such as CoCr, or mixtures thereof.

[0036] Some device embodiments can be formed using from about 10 filaments to about 300 filaments, alternatively from about 10 filaments to about 100 filaments, alternatively from about 60 filaments to about 80 filaments, alternatively from about 72 filaments to about 216 filaments, alternatively from about 150 filaments to about 300 filaments. Some embodiments of the permeable shell can include from about 70 filaments to about 300 filaments, or alternatively from about 100 filaments to about 200 filaments. The wire or filament may have a diameter or transverse dimension of from about 0.0005 inches (about 0.0127 mm) to about 0.003 inches (about 0.0762 mm), alternatively from about 0.001 inches (about 0.0254 mm) to about 0.003 inches (about 0.0762 mm), alternatively from about 0.0015 inches (about 0.0381 mm) to about 0.0025 inches (about 0.0635 mm), alternatively from about 0.0008 inches (about 0.0203 mm) to about 0.004 inches (about 0.1016 mm). In some cases, the elongated elastic filaments can have an outer transverse dimension or diameter of from about 0.0005 inches (about 0.0127 mm) to about 0.005 inches (about 0.127 mm), alternatively from about 0.001 inches (about 0.0254 mm) to about 0.003 inches (about 0.0762 mm), alternatively from about 0.0004 inches (about 0.01016 mm) to about 0.002 inches (about 0.0508 mm).

[0037] In some embodiments, the mesh can be made from a mixture of filaments of different types of materials (e.g., Nitinol and DFT) and / or different sizes of filaments. In some embodiments, the mesh may be made from filaments having a non-uniform or relatively non-uniform distribution. In other embodiments, the mesh may be made from filaments that are relatively uniformly distributed.

[0038] The wires or filaments making up a single mesh can have different transverse diameters and may be made of different materials. In some device embodiments including filaments of different sizes, the larger filaments of the permeable shell may have a transverse dimension or diameter that is about 0.001 inch to about 0.004 inch and the smaller filaments may have a transverse dimension or diameter that is about 0.0004 inch to about 0.0015 inch, or alternatively, about 0.0004 inch to about 0.001 inch. Additionally, the difference in transverse dimension or diameter between the small and large filaments may be less than about 0.004 inches (about 0.1016 mm), alternatively less than about 0.0035 inches (about 0.0889 mm), alternatively less than about 0.002 inches (about 0.0508 mm). For embodiments of permeable shells including filaments of different sizes, the number of small filaments in the permeable shell to the number of large filaments in the permeable shell may be from about 2:1 to about 15:1, more specifically from about 2:1 to about 12:1, and even more specifically from about 4:1 to about 8:1.

[0039] Suitable wire materials and sizes for constructing mesh implants are described in U.S. Patent Application Publication No. 2017 / 0095254, U.S. Patent Application Publication No. 2016 / 0249934, U.S. Patent Application Publication No. 2016 / 0367260, U.S. Patent Application Publication No. 2016 / 0249937, and U.S. Patent Application Publication No. 2018 / 0000489, all of which are expressly incorporated by reference herein in their entireties for all purposes.

[0040] In some embodiments, the implant may comprise a permeable shell with multiple layers of mesh made from a single folded braided mesh with only a proximal hub or marker band proximal to the aneurysm neck. The permeable shell may include two layers with one fold of mesh, or three layers with two folds of mesh, or four layers with three folds of mesh. Methods for making multi-layer permeable shells are described in more detail in U.S. Patent Application Publication No. 2022 / 0257260, which is expressly incorporated by reference in its entirety for all purposes. In some embodiments, the implant may be double layered and made with a folded mesh such that both ends of the filament are located at one end of the device. A proximal hub or marker band 70 may hold both ends of each filament of the multiple filaments.

[0041] In some embodiments, the implant may have a permeable shell with only a single layer of mesh. The proximal hub holds only one end (e.g., proximal end) of each of the multiple filaments that make up the mesh, and the other end (e.g., distal end) of each of the multiple filaments may be free and unbonded at the open distal end 222. Alternatively, the other end of the filament may be woven into the mesh of the permeable shell 240. Alternatively, the second end of the filament may be gathered and held together by an additional hub. The additional hub may be disposed within the open cavity formed by the deployed permeable shell and disposed toward the proximal end 224 of the device 210. The additional hub may be disposed near or adjacent to the proximal hub while being separated by one or more layers of mesh that make up the permeable shell 240. Alternatively, the implant may be single layered and made from a single braided mesh that may be constructed on a castellated mandrel, as described in U.S. Patent Application Publication No. 2021 / 0275184, which is expressly incorporated by reference in its entirety for all purposes. The braided mesh 270 may be constructed using a castellated mandrel such that the filaments are formed into loops 274 with openings 272 centrally located at the distal end, as seen in Figure 6. The ends of the multiple filaments may be secured relative to one another at the proximal end, for example, at the proximal hub or marker band 70.

[0042] It is contemplated that all features, elements, components, functions, and steps described with respect to any embodiment provided herein can be freely combined and substituted with those of any other embodiment. If a feature, element, component, function, or step is described only with respect to one embodiment, it should be understood that the feature, element, component, function, or step can be used with all other embodiments described herein, unless expressly stated otherwise. Therefore, this paragraph always serves as a preliminary basis and written support for the introduction of claims that combine features, elements, components, functions, and steps from different embodiments, or substitute features, elements, components, functions, and steps from one embodiment with those of another embodiment, even if the following description does not expressly state that such combinations or substitutions are possible in a specific example. It can be clearly recognized that explicitly listing all possible combinations and substitutions would be excessively burdensome, and a person skilled in the art would easily recognize that, in particular, each and every such combination and substitution is permissible.

[0043] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0044] Aspects of the invention are set out in the independent claims and preferred features are set out in the dependent claims. Preferred features from the dependent claims may be provided in combination in a single embodiment and preferred features of one aspect may be provided in combination with other aspects.

[0045] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and described in detail herein. However, it should be understood that these embodiments should not be limited to the particular forms disclosed, but rather, these embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the present disclosure. Furthermore, any feature, function, step, or element of the embodiments may be recited or added to the claims, and negative limitations may be made to define the inventive scope of the claims by features, functions, steps, or elements not within the scope.

[0046] In many embodiments, an instrument for treating a cerebral aneurysm in a patient includes a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first end of each of the plurality of elongated filaments being gathered in a hub, the permeable shell having a first unconstrained preset configuration comprising a dome-shaped portion and a collar-shaped portion, the dome-shaped portion having an outer surface, an inner surface, and an interior cavity defined by the inner surface, the hub being positioned within the interior cavity in the first unconstrained preset configuration, the permeable shell being configured to assume a second constrained configuration when deployed within the cerebral aneurysm in the patient, the second constrained configuration having an open distal end.

[0047] In some embodiments, the first unconstrained preset configuration has a hat shape. In some embodiments, the hat shape further comprises a lip. In some embodiments, the lip extends at an acute angle from the brim.

[0048] In some embodiments, the first unconstrained preset configuration has an umbrella shape.

[0049] In some embodiments, the hub is located at a distal end of the first unconstrained preset configuration.

[0050] In some embodiments, the second constrained configuration has a bowl shape.

[0051] In some embodiments, the second constrained configuration further comprises a substantially flat portion at the proximal end.

[0052] In some embodiments, the second constrained configuration has a tulip shape.

[0053] In some embodiments, the second constrained configuration has a cup shape.

[0054] In some embodiments, the hub is located at a proximal end of the second constrained configuration.

[0055] In some embodiments, the first end and the second end of each of the plurality of elongate filaments are gathered into a hub.

[0056] In some embodiments, each of the plurality of elongate filaments comprises an intermediate portion that forms a loop at a distal end of the second constrained configuration.

[0057] In some embodiments, each of the plurality of elongate filaments comprises an intermediate portion that forms a loop at a proximal end of the first unconstrained preset configuration.

[0058] In some embodiments, the distal end of the permeable shell in the first unconstrained preset configuration is inverted.

[0059] In some embodiments, the distal end of the permeable shell in the first unconstrained preset configuration has an outer convex surface.

[0060] In some embodiments, the distal end of the permeable shell in the second constrained configuration has an inner concave surface.

[0061] In some embodiments, the plurality of elongated filaments are disposed in a braided mesh. In some embodiments, the permeable shell comprises a single layer of the braided mesh. In some embodiments, the permeable shell comprises a double layer of the braided mesh. In some embodiments, the permeable shell comprises multiple layers of the braided mesh.

[0062] In many embodiments, a method for treating a cerebral aneurysm having an internal cavity and a neck includes advancing an implant within a microcatheter to a target region of a cerebral artery, the implant comprising a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first end of each of the plurality of elongated filaments being gathered into a hub, the hub being coupled to a pusher, the implant being heat set to a first expanded state comprising a dome-shaped portion, a collar-shaped portion and an open proximal end; advancing the implant distally toward the dome-shaped portion of the cerebral aneurysm, thereby advancing the implant out of the microcatheter and into the internal cavity of the cerebral aneurysm, the permeable shell expanding to a second expanded state in the internal cavity of the aneurysm, the second expanded state comprising an open distal end; detaching the pusher from the implant; and withdrawing the microcatheter from the target region after detaching the implant.

[0063] In some embodiments, the first expanded state has a hat shape.

[0064] In some embodiments, the first expanded state has an umbrella shape.

[0065] In some embodiments, the second expanded state has a bowl shape.

[0066] In some embodiments, the second expanded state further comprises a substantially flat portion at the proximal end.

[0067] In some embodiments, the second expanded state has a tulip shape.

[0068] In some embodiments, the second expanded state has a cup shape.

[0069] In some embodiments, the plurality of elongated filaments are disposed in a braided mesh. In some embodiments, the permeable shell comprises a single layer of the braided mesh. In some embodiments, the permeable shell comprises a double layer of the braided mesh. In some embodiments, the permeable shell comprises multiple layers of the braided mesh.

[0070] In some embodiments, the second expanded shape is different from the first expanded shape.

[0071] In some embodiments, the hub is located at a distal end of the first expanded state.

[0072] In some embodiments, the hub is located at a proximal end of the second expanded state.

[0073] In some embodiments, the first end and the second end of each of the plurality of elongate filaments are gathered into a hub.

[0074] In some embodiments, each of the plurality of elongate filaments includes an intermediate portion that forms a loop at a distal end in the second expanded state.

[0075] In some embodiments, each of the plurality of elongate filaments comprises an intermediate portion that forms a loop at a proximal end in the first expanded state.

[0076] In some embodiments, the distal end of the permeable shell in the first expanded state is inverted.

[0077] In some embodiments, the distal end of the permeable shell in the first expanded state has an outer convex surface.

[0078] In some embodiments, the distal end of the permeable shell in the second expanded state has an inner concave surface.

[0079] In many embodiments, a method for treating a cerebral aneurysm having an internal cavity and a neck includes the steps of advancing an implant within a microcatheter to a target region of a cerebral artery, the implant including a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first end of each of the plurality of elongated filaments being gathered into a hub, the hub being coupled to a pusher, and advancing the implant distally toward a dome of the cerebral aneurysm, thereby advancing the implant out of the microcatheter and into the internal cavity of the cerebral aneurysm, the permeable shell forming a permeable shell in the internal cavity of the aneurysm. the permeable shell assumes a second expanded state position within the internal cavity of the aneurysm, the second expanded state comprising a substantially flat portion at a proximal end and an open distal end, the hub being located at the proximal end of the expanded state; withdrawing the pusher proximally within the internal cavity, the permeable shell assuming a second expanded state position within the internal cavity of the aneurysm, the second expanded state comprising a substantially flat portion at a proximal end and an open distal end, the hub being located at the proximal end of the expanded state; detaching the pusher from the implant; and withdrawing the microcatheter from the region of interest after removing the implant.

[0080] In some embodiments, the first expanded state has a hat shape.

[0081] In some embodiments, the first expanded state has an umbrella shape.

[0082] In some embodiments, each of the plurality of elongate filaments includes an intermediate portion that forms a loop at a distal end in the second expanded state.

[0083] In some embodiments, each of the plurality of elongate filaments comprises an intermediate portion that forms a loop at a proximal end in the first expanded state.

[0084] In some embodiments, the plurality of filaments at a distal end in the first expanded state are inverted.

[0085] In some embodiments, the height of the permeable shell in the second expanded state is less than the height of the cerebral aneurysm.

[0086] In some embodiments, the cerebral aneurysm is a wide-necked cerebral aneurysm.

[0087] In some embodiments, after the implant is deployed, the substantially flat portion fits within the neck of a wide-necked cerebral aneurysm.

[0088] In some embodiments, the hub is removably coupled to the pusher.

[0089] In many embodiments, a device for treating a cerebral aneurysm in a patient includes a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub, the permeable shell having a first unconstrained configuration comprising a closed distal end having an outer convex surface, and the permeable shell is configured to assume a second configuration when deployed within the patient's cerebral aneurysm, the second configuration comprising an open distal end having an inner convex surface.

[0090] In some embodiments, the first unconstrained configuration comprises an umbrella shape.

[0091] In some embodiments, the hub does not contact the outer convex surface.

[0092] In some embodiments, the second configuration comprises a bowl shape.

[0093] In some embodiments, the hub is not located within an internal cavity of the second configuration.

[0094] In many embodiments, a device for treating a cerebral aneurysm in a patient includes a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub, the permeable shell having a first unconstrained configuration comprising a closed distal end having an outer convex surface, and the permeable shell is configured to assume a second configuration when deployed within the cerebral aneurysm in the patient, the second configuration comprising an open distal end and an interior cavity.

[0095] In some embodiments, the first unconstrained configuration comprises an umbrella shape.

[0096] In some embodiments, the hub does not contact the outer convex surface.

[0097] In some embodiments, the second configuration comprises a bowl shape.

[0098] In some embodiments, the hub is not located within the internal cavity of the second component.

[0099] In many embodiments, a device for treating a cerebral aneurysm in a patient includes a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first end of each of the plurality of elongated filaments being gathered into a hub, the permeable shell having a first surface and a second surface, the hub being attached to the second surface, the permeable shell having a first unconstrained configuration comprising a convex portion having an interior cavity, the hub being positioned in the interior cavity of the convex portion in the first unconstrained configuration, and the permeable shell being configured to assume a second configuration when deployed into the cerebral aneurysm in the patient, the second configuration being the inverse of the first unconstrained configuration.

[0100] In some embodiments, a surface of the interior cavity of the convex portion is the second surface.

[0101] In some embodiments, the second configuration comprises an open distal end.

[0102] In some embodiments, the first unconstrained configuration further comprises an open proximal end.

[0103] In some embodiments, the first unconstrained configuration further comprises a planar portion attached to the convex portion, hi some embodiments, the planar portion extends obliquely from the convex portion.

[0104] clauses Exemplary embodiments are described in the following numbered sections: 1. An instrument for treating a cerebral aneurysm in a patient, comprising: a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub; the permeable shell has a first unconstrained preset configuration comprising a dome-shaped portion and a collar-shaped portion, the dome-shaped portion comprising an outer surface, an inner surface, and an interior cavity defined by the inner surface, the hub being positioned within the interior cavity in the first unconstrained preset configuration; the permeable shell is configured to assume a second constrained configuration when deployed within the patient's cerebral aneurysm, the second constrained configuration comprising an open distal end. Equipment. Clause 2. The apparatus of clause 1, wherein the first unconstrained preset configuration has a hat shape. Clause 3. The device of clause 2, wherein the hat shape further comprises a lip. Clause 4. The device of clause 3, wherein the lip extends from the flange at an acute angle. Clause 5. The apparatus of clause 1, wherein the first unconstrained preset configuration has an umbrella shape. Clause 6. The instrument of clause 1, wherein the hub is located at a distal end of the first unconstrained preset configuration. Clause 7. The apparatus of clause 1, wherein the second constrained configuration has a bowl shape. Clause 8. The apparatus of clause 1, wherein the second constrained configuration further comprises a substantially flat portion at a proximal end. Clause 9. The apparatus of clause 1, wherein the second constrained configuration has a tulip shape. Clause 10. The apparatus of clause 1, wherein the second constrained configuration has a cup shape. Clause 11. The apparatus of clause 1, wherein the hub is located at a proximal end of the second constrained configuration. Clause 12. The device of clause 1, wherein the first end and the second end of each of the plurality of elongate filaments are gathered in a hub. Clause 13. The device of clause 1, wherein each of the plurality of elongate filaments comprises an intermediate portion, the intermediate portion forming a loop at a distal end of the second constrained configuration. Clause 14. The device of clause 1, wherein each of the plurality of elongate filaments comprises an intermediate portion, the intermediate portion forming a loop at a proximal end of the first unconstrained preset configuration. Clause 15. The apparatus of clause 1, wherein a distal end of the permeable shell in the first unconstrained preset configuration is inverted. Clause 16. The apparatus of clause 1, wherein a distal end of the permeable shell in the first unconstrained preset configuration has an outer convex surface. Clause 17. The apparatus of clause 1, wherein a distal end of the permeable shell in the second constrained configuration has an internal concave surface. Clause 18. The device of clause 1, wherein the plurality of elongated filaments are arranged in a braided mesh. Clause 19. The device of clause 18, wherein the permeable shell comprises a single layer of the braided mesh. Clause 20. The device of clause 18, wherein the permeable shell comprises a double layer of the braided mesh. Clause 21. The device of clause 18, wherein the permeable shell comprises multiple layers of the braided mesh. 22. A method for treating a cerebral aneurysm having an internal cavity and a neck, comprising: advancing an implant within a microcatheter to a target region within a cerebral artery, the implant comprising a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub, the hub being coupled to a pusher, the implant being heat set in a first expanded state comprising a dome-shaped portion, a collar-shaped portion and an open proximal end; advancing the implant out of the microcatheter and into the interior cavity of the cerebral aneurysm by advancing the implant distally toward a dome of the cerebral aneurysm, wherein the permeable shell expands to a second expanded state in the interior cavity of the aneurysm, the second expanded state comprising an open distal end; removing the pusher from the implant; withdrawing the microcatheter from the area of ​​interest after removing the implant; The method includes: Clause 23. The method of clause 22, wherein the first expanded state has a hat shape. Clause 24. The method of clause 22, wherein the first expanded state has an umbrella shape. Clause 25. The method of clause 22, wherein the second expanded state has a bowl shape. Clause 26. The method of clause 22, wherein the second expanded state further comprises a substantially flat portion at a proximal end. Clause 27. The method of clause 22, wherein the second expanded state has a tulip shape. Clause 28. The method of clause 22, wherein the second expanded state has a cup shape. Clause 29. The method of clause 22, wherein the plurality of elongated filaments are arranged in a braided mesh. Clause 30. The method of clause 29, wherein the permeable shell comprises a single layer of the braided mesh. Clause 31. The method of clause 29, wherein the permeable shell comprises a double layer of the braided mesh. Clause 32. The method of clause 29, wherein the permeable shell comprises multiple layers of the braided mesh. Clause 33. The method of clause 22, wherein the second expanded shape is different from the first expanded shape. Clause 34. The method of clause 22, wherein the hub is located at a distal end in the first expanded state. Clause 35. The method of clause 22, wherein the hub is located at a proximal end in the second expanded state. Clause 36. The method of clause 22, wherein the first end and the second end of each of the plurality of elongated filaments are gathered in a hub. Clause 37. The method of clause 22, wherein each of the plurality of elongate filaments includes an intermediate portion, the intermediate portion forming a loop at a distal end in the second expanded state. Clause 38. The method of clause 22, wherein each of the plurality of elongate filaments includes an intermediate portion, the intermediate portion forming a loop at a proximal end in the first expanded state. Clause 39. The method of clause 22, wherein a distal end of the permeable shell in the first expanded state is everted. Clause 40. The method of clause 22, wherein the distal end of the permeable shell in the first expanded state has an outer convex surface. Clause 41. The method of clause 22, wherein the distal end of the permeable shell in the second expanded state has an internal concave surface. 42. A method for treating a cerebral aneurysm having an internal cavity and a neck, comprising: advancing an implant within a microcatheter to a target region within a cerebral artery, the implant comprising a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub, the hub being coupled to a pusher; advancing the implant out of the microcatheter and into the internal cavity of the cerebral aneurysm by advancing the implant distally toward a dome of the cerebral aneurysm, wherein the permeable shell expands to a first expanded state in the internal cavity of the aneurysm, the first expanded state comprising a dome-shaped portion and a brim-shaped portion, the dome-shaped portion comprising an outer surface, an inner surface, and an internal cavity defined by the inner surface, and the hub is located within the internal cavity at a distal end of the first expanded state; withdrawing the pusher proximally within the interior cavity, the permeable shell assuming a second expanded state within the interior cavity of the aneurysm, the second expanded state comprising a substantially flattened portion at a proximal end and an open distal end, the hub being located at the proximal end of the expanded state; removing the pusher from the implant; withdrawing the microcatheter from the area of ​​interest after removing the implant; The method includes: Clause 43. The method of clause 42, wherein the first expanded state has a hat shape. Clause 44. The method of clause 42, wherein the first expanded state has an umbrella shape. Clause 45. The method of clause 42, wherein each of the plurality of elongate filaments includes an intermediate portion, the intermediate portion forming a loop at a distal end in the second expanded state. Clause 46. The method of clause 42, wherein each of the plurality of elongate filaments includes an intermediate portion, the intermediate portion forming a loop at a proximal end in the first expanded state. Clause 47. The method of clause 42, wherein the plurality of filaments at a distal end in the first expanded state are inverted. Clause 48. The method of clause 42, wherein the height of the permeable shell in the second expanded state is less than the height of the cerebral aneurysm. Clause 49. The method of clause 42, wherein the cerebral aneurysm is a wide-necked cerebral aneurysm. Clause 50. The method of clause 42, wherein after the implant is deployed, the substantially flat portion fits within the neck of a wide-necked cerebral aneurysm. Clause 51. The method of clause 42, wherein the hub is removably coupled to the pusher. 52. An apparatus for treating a cerebral aneurysm in a patient, comprising: a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub; the permeable shell has a first, unconstrained configuration with a closed distal end having an outer convex surface; the permeable shell is configured to adopt a second configuration when deployed within the patient's cerebral aneurysm, the second configuration comprising an open distal end having an internal convex surface. Equipment. 53. An apparatus for treating a cerebral aneurysm in a patient, comprising: a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub; the permeable shell has a first, unconstrained configuration with a closed distal end having an outer convex surface; the permeable shell is configured to assume a second configuration when deployed within the patient's cerebral aneurysm, the second configuration comprising an open distal end and an interior cavity. Equipment. Clause 54. The apparatus of clause 53, wherein the first unconstrained configuration comprises an umbrella shape. Clause 55. The instrument of clause 53, wherein the hub is not in contact with the outer convex surface. Clause 56. The apparatus of clause 53, wherein the second configuration comprises a bowl shape. Clause 57. The apparatus of clause 53, wherein the hub is not located within an internal cavity of the second configuration. 58. An apparatus for treating a cerebral aneurysm in a patient, comprising: a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub, the permeable shell having a first surface and a second surface, the hub being attached to the second surface; the permeable shell has a first unconstrained configuration comprising a convex portion having an internal cavity, the hub being positioned within the internal cavity of the convex portion in the first unconstrained configuration; the permeable shell is configured to assume a second configuration when deployed within the patient's cerebral aneurysm, the second configuration being an inverse of the first unconstrained configuration. Equipment. Clause 59. The apparatus of clause 58, wherein a surface of the interior cavity of the convex portion is the second surface. Clause 60. The instrument of clause 58, wherein the second configuration comprises an open distal end. Clause 61. The apparatus of clause 58, wherein the first unconstrained configuration further comprises an open proximal end. Clause 62. The apparatus of clause 58, wherein the first unconstrained configuration further comprises a planar portion attached to the convex portion. Clause 63. The apparatus of clause 62, wherein the planar portion extends obliquely from the convex portion.

Claims

1. 1. An apparatus for treating a cerebral aneurysm in a patient, comprising: a permeable shell made from a plurality of elongated filaments, each of the plurality of filaments having a first end and a second end, the first ends of each of the plurality of elongated filaments being gathered into a hub; the permeable shell has a first unconstrained preset configuration comprising a dome-shaped portion and a collar-shaped portion, the dome-shaped portion having an outer surface, an inner surface, and an interior cavity defined by the inner surface, the hub being positioned within the interior cavity in the first unconstrained preset configuration; the permeable shell is configured to assume a second constrained configuration when deployed within the patient's cerebral aneurysm, the second constrained configuration comprising an open distal end. Equipment.

2. The device of claim 1 , wherein the first unconstrained preset configuration has a hat shape.

3. The device of claim 2 , wherein the hat shape further comprises a lip.

4. The device of claim 3 , wherein the lip extends from the collar at an acute angle.

5. The instrument of claim 1 , wherein the first unconstrained preset configuration has an umbrella shape.

6. The instrument of claim 1 , wherein the hub is located at a distal end of the first unconstrained preset configuration.

7. The apparatus of claim 1 , wherein the second constrained configuration has a bowl shape.

8. The device of claim 1 , wherein the second constrained configuration further comprises a substantially flat portion at a proximal end.

9. The device of claim 1 , wherein the second constrained configuration has a tulip shape.

10. The device of claim 1 , wherein the second constrained configuration has a cup shape.

11. The device of claim 1 , wherein the hub is located at a proximal end of the second constrained configuration.

12. The device of claim 1 , wherein the first end and the second end of each of the plurality of elongate filaments are gathered into a hub.

13. The device of claim 1 , wherein each of the plurality of elongate filaments comprises an intermediate portion, the intermediate portion forming a loop at a distal end of the second constrained configuration.

14. The device of claim 1 , wherein each of the plurality of elongate filaments comprises an intermediate portion, the intermediate portion forming a loop at a proximal end of the first unconstrained preset configuration.

15. The device of claim 1 , wherein the distal end of the permeable shell in the first unconstrained preset configuration is inverted.

16. The device of claim 1 , wherein the distal end of the permeable shell in the first unconstrained preset configuration has an outer convex surface.

17. The device of claim 1 , wherein the distal end of the permeable shell in the second constrained configuration has an inner concave surface.

18. The device of claim 1 , wherein the plurality of elongated filaments are arranged in a braided mesh.

19. 20. The device of claim 18, wherein the permeable shell comprises a single layer of the braided mesh.

20. 20. The device of claim 18, wherein the permeable shell comprises a double layer of the braided mesh.

21. 20. The device of claim 18, wherein the permeable shell comprises multiple layers of the braided mesh.

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